Hatch aims to promote biosimilars and generics and restrict litigation

Home/Policies & Legislation | Posted 13/07/2018 post-comment0 Post your comment

Senator Orrin Hatch filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which was advanced to the Senate by the Judiciary Committee on 14 June 2018.

Law V13C29

The Senator’s amendment, called the Hatch-Waxman Integrity Act  of 2018, aims to restore the careful balance the Hatch-Waxman Act struck to incentivize generics development. Senator Hatch’s legislation aims to prevent alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design. It would also ensure that brand-name and generic drug manufacturers alike have the proper incentives to develop life-saving medications.

The proposed amendment would require that a generic drug applicant certify that it has not filed – nor does it plan to file – a petition to institute an inter partes review (IPR) or post-grant review (PGR) for a patent covering the innovator drug; in essence, if a generic developer hopes to use the abbreviated Hatch-Waxman pathway to approval, it must promise not to utilize the IPR or PGR process. The amendment makes a similar provision for biosimilars; if a biosimilar developer plans to use the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) approval pathway for its product, it must certify that it has not filed, and will not file, a petition to institute an IPR or PGR.

Senator Hatch believes that his ‘amendment will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments’.

Related articles
US introduces bill to close drug patent loophole

US Senate revives the CREATES Act

Generics makers challenging more patents

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Hatch

comment icon Comments (0)
Post your comment
Related content
Panama embraces international pharmacovigilance standards
Pharmacovigilance V13F21
Home/Policies & Legislation Posted 09/07/2024
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010